Race-specific FRAX models are evidence-based and support equitable care: a response to the ASBMR Task Force report on Clinical Algorithms for Fracture Risk.

Task Force on 'Clinical Algorithms for Fracture Risk' commissioned by the American Society for Bone and Mineral Research (ASBMR) Professional Practice Committee has recommended that FRAX® models in the US do not include adjustment for race and ethnicity. This position paper finds that an agnostic model would unfairly discriminate against the Black, Asian and Hispanic communities and recommends the retention of ethnic and race-specific FRAX models for the US, preferably with updated data on fracture and death hazards. In contrast, the use of intervention thresholds based on a fixed bone mineral density unfairly discriminates against the Black, Asian and Hispanic communities in the US. This position of the Working Group on Epidemiology and Quality of Life of the International Osteoporosis Foundation (IOF) is endorsed both by the IOF and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

Association between institutionalization by 4 months post-discharge walking capacity and lean body mass in elderly hip fracture patients: Evidence from a Swedish Registry Based Study.

Background and purpose: Losing independence is a main concern for hip fracture patients, and particularly not being able to return home. Given the large impact on quality of life by loss of independence and the high risk for institutionalization after hip fracture, it is of importance to identify modifiable risk factors for such negative outcomes. This study aimed to investigate the association between two such factors, that is, lean body mass and 4 months post-discharge walking capacity, and the risk of institutionalization in previously independent living older people who suffer a hip fracture. Patients and methods: A retrospective cohort study was conducted using Swedish national-based population registers. Patients ⩾60 years with a hip fracture during 2008-2017 were included from the Swedish National Registry for Hip Fractures. Risk of institutionalization over the 1-year period following a hip fracture was analyzed using logistic regression analyses adjusted for potential predictors and characteristics. Results: In total, 11,265 patients were included. Over the first year, 8% (95% CI: 8-9) of the patients with a hip fracture had lost independence, increasing to 15% (95% CI: 14-16) after 5 years. Poor recovery of post-discharge walking ability was associated with a higher odds ratio of losing independence compared with good recovery (OR 12.0; 95% CI: 7.8-18.4; p < 0.001). Having higher estimated lean body mass than 45 kg at index was associated with lower odds of losing independence. Conclusion: Maintaining lean body mass and mobility after a hip fracture is likely important from an individual as well as public health perspective.

Cost-effectiveness of romosozumab for the treatment of postmenopausal women with osteoporosis at high risk of fracture in Belgium.

This study evaluated the cost-effectiveness of sequential treatment with romosozumab-to-alendronate compared to alendronate monotherapy and teriparatide-to-alendronate, in postmenopausal osteoporotic women from a Belgian healthcare perspective. Romosozumab-to-alendronate was found to be cost-effective compared to alendronate monotherapy and dominant compared to teriparatide-to-alendronate for osteoporotic women at high risk of fracture in Belgium. PURPOSE: This study aimed to evaluate the cost-effectiveness of sequential treatment with romosozumab followed by alendronate compared to alendronate monotherapy and teriparatide followed by alendronate, in postmenopausal osteoporotic women at high risk of fracture, from a Belgian healthcare perspective. Romosozumab is reimbursed in Belgium since December 2021. METHODS: A Markov microsimulation model was used to evaluate the cost-effectiveness of romosozumab-to-alendronate compared to alendronate monotherapy and to teriparatide-to-alendronate over a lifetime horizon. Patients transition between five different health states every 6 months based on fracture risks or death. The model was populated with Belgium-specific epidemiological and cost data, where available. The fracture risk reduction of romosozumab treatment was collated from the ARCH study, and from a published network meta-analysis. Costs were included from a healthcare perspective (NIHDI). Cost-effectiveness was reported in terms of costs per quality-adjusted life year (QALY), reported in Euro (€) 2022. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were performed. RESULTS: Romosozumab-to-alendronate was associated with 0.12 additional QALYs at an additional cost of €2314 compared to alendronate monotherapy, resulting in an ICER of €19,978. Compared to teriparatide-to-alendronate, romosozumab-to-alendronate was found to be dominant, with higher QALYs and lower costs. The base-case results were robust to uncertainty in the input parameters when conducting the sensitivity analysis. CONCLUSION: Sequential treatment with romosozumab followed by alendronate was found to be cost-effective compared to alendronate monotherapy and dominant compared to teriparatide followed by alendronate for postmenopausal women with osteoporosis at high risk of fracture in Belgium.

Real-world outcomes in spinal cord stimulation: predictors of reported effect and explantation using a comprehensive registry-based approach.

Introduction: Despite advancements in implanted hardware and development of novel stimulation paradigms in Spinal Cord Stimulation (SCS), real world evidence suggests a large variation in patient reported outcomes and a proportion of patients are later explanted due to loss of analgesia. Possible predictors for outcome have been explored in smaller short-term evaluations, but few clinically applicable robust measures for long term outcome have emerged. Methods: We performed a comprehensive retrospective study based on an assembled patient-level aggregated database from multiple local and national registries in Sweden. Variables associated with risk of explantation (due to insufficient analgesia) and analgesic effect was analyzed using a Cox regression analysis and an ordered logit regression model, respectively. Results: We found the accumulated risk of explantation due to loss of analgesia to be 10% and 21% at two and ten years follow up, respectively. The use of 10 kHz spinal cord stimulation (compared with Tonic waveform; p = 0.003), and being 60 years or older (reference 18-40 years; p = 0.003) were associated with an increased risk of explantation.At a mean follow up at 1 year, 48% of patients reported a pain intensity reduction from baseline of at least 30%. Secondary (p = 0.030) and post-secondary (p = 0.001) education (compared with primary education) was associated with an increased probability of successful patient reported outcomes. Conclusion: This study suggests that a higher educational level and being employed are associated with successful treatment outcome in patients with chronic pain treated with SCS in Sweden.

Impact of spinal cord stimulation on sick leave and disability pension in patients with chronic neuropathic pain: a real-world evidence study in Sweden.

ABSTRACT: Current research indicates that spinal cord stimulation (SCS) has a positive short-term impact on outcomes, such as quality of life, pain, and productivity in patients with chronic neuropathic pain. However, there is a need for studies on larger population samples. This study used data from Swedish national registers to analyze change and predictors of sick leave and disability pension 2 years before and after SCS treatment. Patients with SCS implanted between 2006 and 2017, and a reference group consisting of 5 individuals matched to each SCS patient without replacement with respect to age, sex, and region of residence, were included. A difference-in-difference approach was used to compare the average change (2 years after treatment vs 2 years before treatment) in net disability days and indirect cost related to disability days for the SCS group, compared with the average change for the reference group. The results showed that SCS treatment in Sweden is associated with a decrease of 21 disability days and consequent decrease in indirect cost of €4127 in working age patients. Large work loss prior to index date was also demonstrated (average 214 days before 1 year), indicating a significant burden on the patient, employers, and the society at large. The number of disability days varied considerably depending on age, sex, socioeconomic variables, and comorbidities; however, the effect of SCS seemed to have little association with patient characteristics. This economic benefit needs to be considered, as well as the clinical outcome, when evaluating the full societal value of SCS.

Osteoporosis in Europe: a compendium of country-specific reports.

This report describes epidemiology, burden, and treatment of osteoporosis in each of the 27 countries of the European Union plus Switzerland and the UK (EU 27+2). INTRODUCTION: The aim of this report was to characterize the burden of osteoporosis in each of the countries of the European Union plus Switzerland and the UK in 2019 and beyond. METHODS: The data on fracture incidence and costs of fractures in the EU27+2 was taken from a concurrent publication in this journal (SCOPE 2021: a new scorecard for osteoporosis in Europe) and country-specific information extracted. The information extracted covered four domains: burden of osteoporosis and fractures; policy framework; service provision; and service uptake. RESULTS: The clinical and economic burden of osteoporotic fractures in 2019 is given for each of the 27 countries of the EU plus Switzerland and the UK. Each domain was ranked and the country performance set against the scorecard for all nations studied. Data were also compared with the first SCOPE undertaken in 2010. Fifteen of the 16 score card metrics on healthcare provision were used in the two surveys. Scores had improved or markedly improved in 15 countries, remained constant in 8 countries and worsened in 3 countries. The average treatment gap increased from 55% in 2010 to 71% in 2019. Overall, 10.6 million women who were eligible for treatment were untreated in 2010. In 2019, this number had risen to 14.0 million. CONCLUSIONS: In spite of the high cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by aging populations, the use of pharmacological prevention of osteoporosis has decreased in recent years, suggesting that a change in healthcare policy concerning the disease is warranted.

Costs of patient management over 18 months following a hip, clinical vertebral, distal forearm, or proximal humerus fragility fracture in France-results from the ICUROS study.

This observational study prospectively assessed direct and indirect costs related to patient management over 18 months following hip, clinical vertebral, humeral, or distal forearm fracture events in France. It appears that their levels were much higher than the previous estimates, raising the burden of osteoporosis-related fractures on public health expenditures. INTRODUCTION: This prospective observational study assessed the costs related to patient management over the 18-month period following the event of a hip, clinical vertebral, humeral, or distal forearm fracture in France. METHODS: Individuals aged ≥ 50 years old with the diagnosis of a fragility fracture in six French University Hospitals were enrolled in the International Costs and Utilities Related to Osteoporotic Fractures Study (ICUROS). All resources used over the defined period and related to fracture and the underlying osteoporosis management were collected by questionnaires at baseline, 4 months, 12 months, and 18 months. Information was collected by direct or phone contact completed by patients' records and interviews of partner, family, and general practitioners. Costs were estimated from a societal perspective, including direct and indirect costs. We implemented recursive partitioning analysis (RPA), a statistical learning algorithm to identify predictors of costs. RESULTS: Four hundred thirty-one patients (mean age 72.5 years; 84.6% women) were evaluated. Among them, 17.6% had a prior fracture in the last 5 years. Approximately half of the whole group lived alone in the community, and 56.8% were from a low- or middle-income category. Over the 18-month period of evaluation, total costs (including initial fracture-related and follow-up ones) were 23 926 €, 14 561 €, and 6 905 € for the hip, clinical vertebral, and distal forearm fracture, respectively. Over a year, costs related to a humeral fracture were 10 319 €. The RPA identified mobility impairment prior to fracture as a predictor of increase in costs related to fracture. CONCLUSIONS: Our study for the first time prospectively assessed total costs related to the four main osteoporotic fractures in France. It appears that their levels were much higher than previous estimates, raising the burden of osteoporosis-related fractures on public health expenditures.

Recovery of quality of life is associated with lower mortality 5-year post-fracture: the Australian arm of the International Costs and Utilities Related to Osteoporotic Fractures Study (AusICUROS).

Little is known about factors that lead to excess mortality post-fracture. This study demonstrated that 5-year mortality is lower in older adults who recovered to their pre-fracture health-related quality of life (HRQoL) at 12-months compared to those who did not recover. Our results highlight the importance of post-fracture interventions known to improve HRQoL. INTRODUCTION: Fragility fractures lead to increased mortality and decreased health-related quality of life (HRQoL) in older adults, although whether an association exists between these outcomes remains uncertain. The aim of this study was to determine whether recovery of HRQoL 12-month post-fracture is associated with lower 5-year mortality. METHODS: This data linkage study included 524 adults (mean age: 70.2 years; 79.2% women) with fragility fracture (150 hip, 261 distal forearm, 61 vertebral, 52 humerus) from the Australian arm of the International Costs and Utilities Related to Osteoporotic fractures Study (AusICUROS). HRQoL was measured using the EQ-5D-3L and all-cause mortality post-fracture was ascertained from the Australian National Death Index (NDI). Cox proportional hazards models were used to assess the association between HRQoL recovery (vs. non-recovery) and all-cause mortality within 5 years. RESULTS: Overall, 279 participants (53.2%) recovered to their pre-fracture HRQoL at 12-month follow-up. There were 70 deaths (13.4%) during the 5-year post-fracture. Mortality rate was the highest in hip fracture participants (24.7%), followed by vertebral (16.4%), humeral (13.5%), and distal forearm fracture participants (6.1%). After adjustment for age, pre-fracture HRQoL, and fracture site, mortality risk was lower in participants who recovered to their pre-fracture HRQoL at 12-months compared to those who did not recover (HR = 0.56, 95% CI: 0.33-0.96, p = 0.034). CONCLUSION: This study provides evidence that HRQoL recovery post-fracture is associated with improved 5-year survival in older adults. The extent to whether current interventions known to improve HRQoL post-fracture could prevent some of these deaths is unknown.

SCOPE 2021: a new scorecard for osteoporosis in Europe.

This scorecard summarises key indicators of the burden of osteoporosis and its management in the 27 member states of the European Union, as well as the UK and Switzerland. The resulting scorecard elements, assembled on a single sheet, provide a unique overview of osteoporosis in Europe. INTRODUCTION: The scorecard for osteoporosis in Europe (SCOPE) is a project of the International Osteoporosis Foundation (IOF) that seeks to raise awareness of osteoporosis care in Europe. The aim of this project was to develop a scorecard and background documents to draw attention to gaps and inequalities in the provision of primary and secondary prevention of fractures due to osteoporosis. METHODS: The SCOPE panel reviewed the information available on osteoporosis and the resulting fractures for each of the 27 countries of the European Union plus the UK and Switzerland (termed EU27+2). The information obtained covered four domains: background information (e.g. the burden of osteoporosis and fractures), policy framework, service provision and service uptake, e.g. the proportion of men and women at high risk that do not receive treatment (the treatment gap). RESULTS: There was a marked difference in fracture risk among the EU27+2 countries. Of concern was the marked heterogeneity in the policy framework, service provision and service uptake for osteoporotic fracture that bore little relation to the fracture burden. For example, despite the wide availability of treatments to prevent fractures, in the majority of the EU27+2, only a minority of patients at high risk receive treatment even after their first fracture. The elements of each domain in each country were scored and coded using a traffic light system (red, orange, green) and used to synthesise a scorecard. The resulting scorecard elements, assembled on a single sheet, provide a unique overview of osteoporosis in Europe. CONCLUSIONS: The scorecard enables healthcare professionals and policy makers to assess their country's general approach to the disease and provide indicators to inform the future provision of healthcare.

Health insurance utilisation after ischaemic stroke in Sweden: a retrospective cohort study in a system of universal healthcare and social insurance.

BACKGROUND: Stroke is one of the largest single-condition sources of the global burden of non-communicable disease in terms of disability-adjusted life-years and monetary costs, directly as well as indirectly in terms of informal care and productivity loss. The objective was to assess the population afflicted with ischaemic stroke in working age in the context of universal healthcare and social insurance; to estimate the levels of absence from work, the indirect costs related to that and to assess the associated patient characteristics. METHODS: This was a retrospective register-based study; all individuals registered with an ischaemic stroke during 2008-2011 in seven Swedish regions, covering the largest cities as well as more rural areas, were included. Individual-level data were used to compute net days of sick leave and disability pension, indirect costs due to productivity loss and to perform regression analysis on net absence from work to assess the associated factors. Costs related to productivity loss were estimated using the human capital approach. RESULTS: Women had significantly fewer net days of sick leave and disability pension than men after multivariable adjustment, and high-income groups had higher levels of sick leave than low-income groups. There were no significant differences for participants regarding educational level, region of birth or civil status. Indirect monetary costs amounted to €17 400 per stroke case during the first year, totalling approximately €169 million in Sweden. CONCLUSION: The individual's burden of stroke is heavy in terms of morbidity, and the related productivity loss for society is immense. Income-group differences point to a socioeconomic gradient in the utilisation of the Swedish social insurance.

Health service use pathways associated with recovery of quality of life at 12-months for individual fracture sites: Analyses of the International Costs and Utilities Related to Osteoporotic fractures Study (ICUROS).

PURPOSE: We aimed to identify combinations of health service use specific to each major osteoporotic fracture (MOF) site - hip, distal forearm, vertebrae and humerus - associated with recovery of health-related quality of life (HRQoL) 12-months post-MOF. METHODS: Patients were 4126 adults aged ≥50 years with a MOF (1657 hip, 1354 distal forearm, 681 vertebral, 434 humerus) from the International Costs and Utilities Related to Osteoporotic fractures Study (Australia, Austria, Estonia, France, Italy, Lithuania, Mexico, Russia, Spain and the UK). HRQoL (pre-fracture and 12-months post-fracture) was measured using the EQ-5D-3L. Health service use data were collected via interviews and medical record reviews and included in-hospital care, outpatient care, supported living, community health services, and medication use. Latent class analyses were undertaken to identify different combinations of health service use ("classes"); and logistic regression to assess associations between classes and HRQoL recovery. Fracture site-specific analyses were performed using pooled data from all 10 countries. RESULTS: The proportion of patients who recovered to their pre-fracture HRQoL at 12-month follow-up varied across fracture sites: 37.3%, 65.8%, 48.9% and 49.5% for hip, distal forearm, vertebrae, and humerus, respectively. We observed several site-specific classes associated with improved odds of HRQoL recovery. Generally, the combination of hospital presentations without admission; primary care center visits; use of osteoporosis-related medications; vitamin D/calcium supplementation; and non-opioid analgesic use was associated with greater likelihood of HRQoL recovery. CONCLUSION: The identified fracture site-specific health service use pathways associated with recovery of HRQoL could potentially improve the management and health outcomes of patients treated for a MOF.

Health Service Use and Quality of Life Recovery 12 Months Following Major Osteoporotic Fracture: Latent Class Analyses of the International Costs and Utilities Related to Osteoporotic Fractures Study (ICUROS).

Major osteoporotic fractures (MOFs) are associated with a rapid decline in health-related quality of life (HRQoL); however, there is limited knowledge about which healthcare services positively affect HRQoL postfracture. This study aimed to identify specific combinations of health service use associated with recovery of HRQoL 12 months post-MOF. The analyses included 4126 adults aged ≥50 years with an MOF (1657 hip, 1354 distal forearm, 681 vertebrae, 434 humerus) participating in the International Costs and Utilities Related to Osteoporotic fractures Study (ICUROS), a multinational observational study (Australia, Austria, Estonia, France, Italy, Lithuania, Mexico, Russia, Spain, United Kingdom, and United States). HRQoL at prefracture and 12 months postfracture was measured using the EuroQoL questionnaire (EQ-5D-3L). Health service use data were collected via participant interviews and medical record reviews including in-hospital care; outpatient care; community services; and medication use. Data analyses involved two stages: (i) latent class analyses to identify different combinations of health service use ("classes"); and (ii) logistic regression to assess effects of classes on HRQoL recovery. Analyses were repeated excluding hip fractures (non-hip MOFs). Overall, 2057 MOF participants (49.9%) recovered to their prefracture HRQoL at 12-month follow-up; this proportion was higher for non-hip MOFs (n = 1439; 58.3%). Several distinct classes were identified across countries (range, 2-5 classes). Classes that were associated with increased odds of HRQoL recovery were characterized by a combination of hospital presentations without admission; outpatient department visits; allied health visits; vitamin D/calcium supplementation; and/or non-opioid analgesic use. Similar classes were observed for non-hip MOFs. Understanding country-specific healthcare service pathways that influence greater recovery of HRQoL, particularly services that are uncommon in some countries and routine in others, could improve postfracture care on a global scale. © 2020 American Society for Bone and Mineral Research (ASBMR).

Economic consequences of migraine in Sweden and implications for the cost-effectiveness of onabotulinumtoxinA (Botox) for chronic migraine in Sweden and Norway.

BACKGROUND: Migraine is a common and incapacitating condition, with severe impact on the quality of life (QoL) of the afflicted and their families, and negative economic consequences through decreased workforce participation, reduced functional ability and elevated healthcare costs. This study aimed to describe the economic consequences of migraine in Sweden using cost of illness survey data and, based on this data, assess the cost-effectiveness of onabotulinumtoxinA (Botox) for the treatment of chronic migraine in Sweden and Norway. METHODS: A survey study was conducted in Swedish migraine patients, with questions on patient characteristics, headache frequency and severity, effect on daily activities and work, QoL, health resource utilization, and medication use. Resulting costs were estimated as annual averages over subgroups of average monthly headache days. Some results were used to inform a Markov cost-effectiveness chronic migraine model. The model was adapted to Sweden and Norway using local data. The analysis perspective was semi-societal. Results' robustness was tested using one-way, structural, and probabilistic sensitivity analyses. RESULTS: Results from the cost of illness analysis (n = 454) indicated a clear correlation between decreased QoL and increased costs with increasing monthly headache days. Total annual costs ranged from EUR 6221 in patients with 0-4 headache days per month, to EUR 57,832 in patients with 25-31. Indirect costs made up the majority of costs, ranging from 82% of total costs in the 0-4 headache days group, to 91% in 25-31 headache days. The cost-effectiveness analyses indicated that in Sweden, Botox was associated with 0.223 additional QALYs at an additional cost of EUR 4126 compared to placebo, resulting in an incremental cost-effectiveness ratio (ICER) of EUR 18,506. In Norway, Botox was associated with 0.216 additional QALYs at an additional cost of EUR 4301 compared to placebo, resulting in an ICER of EUR 19,954. CONCLUSIONS: In people with migraine, an increase in monthly headache days is clearly related to lower QoL and higher costs, indicating considerable potential costs-savings in reducing the number of headache days. The main cost driver for migraine is indirect costs. Botox reduces headache days and is a cost-effective treatment for chronic migraine in Sweden and Norway.

Fragility fractures in Europe: burden, management and opportunities.

This report provides an overview and a comparison of the burden and management of fragility fractures in the largest five countries of the European Union plus Sweden (EU6). In 2017, new fragility fractures in the EU6 are estimated at 2.7 million with an associated annual cost of €37.5 billion and a loss of 1.0 million quality-adjusted life years. INTRODUCTION: Osteoporosis is characterized by reduced bone mass and strength, which increases the risk of fragility fractures, which in turn, represent the main consequence of the disease. This report provides an overview and a comparison of the burden and management of fragility fractures in the largest five EU countries and Sweden (designated the EU6). METHODS: A series of metrics describing the burden and management of fragility fractures were defined by a scientific steering committee. A working group performed the data collection and analysis. Data were collected from current literature, available retrospective data and public sources. Different methods were applied (e.g. standard statistics and health economic modelling), where appropriate, to perform the analysis for each metric. RESULTS: Total fragility fractures in the EU6 are estimated to increase from 2.7 million in 2017 to 3.3 million in 2030; a 23% increase. The resulting annual fracture-related costs (€37.5 billion in 2017) are expected to increase by 27%. An estimated 1.0 million quality-adjusted life years (QALYs) were lost in 2017 due to fragility fractures. The current disability-adjusted life years (DALYs) per 1000 individuals age 50 years or more were estimated at 21 years, which is higher than the estimates for stroke or chronic obstructive pulmonary disease. The treatment gap (percentage of eligible individuals not receiving treatment with osteoporosis drugs) in the EU6 is estimated to be 73% for women and 63% for men; an increase of 17% since 2010. If all patients who fracture in the EU6 were enrolled into fracture liaison services, at least 19,000 fractures every year might be avoided. CONCLUSIONS: Fracture-related burden is expected to increase over the coming decades. Given the substantial treatment gap and proven cost-effectiveness of fracture prevention schemes such as fracture liaison services, urgent action is needed to ensure that all individuals at high risk of fragility fracture are appropriately assessed and treated.

Quality of life after fragility fracture in the Russian Federation: results from the Russian arm of the International Cost and Utility Related to Osteoporotic Fractures Study (ICUROS).

Changes in health-related quality of life (QoL) due to hip, humeral, ankle, spine, and distal forearm fracture were measured in Russian adults age 50 years or more over the first 18 months after fracture. The accumulated mean QoL loss after hip fracture was 0.5 and significantly greater than after fracture of the distal forearm (0.13), spine (0.21), proximal humerus (0.26), and ankle (0.27). INTRODUCTION: Data on QoL following osteoporotic fractures in Russia are scarce. The present study evaluated the impact of hip, vertebral, proximal humerus, distal forearm, and ankle fracture up to 18 months after fracture from the Russian arm of the International Costs and Utilities Related to Osteoporotic Fractures Study. METHODS: Individuals age ≥ 50 years with low-energy-induced humeral, hip, clinical vertebral, ankle, or distal forearm fracture were enrolled. After a recall of pre-fracture status, HRQoL was prospectively collected over 18 months of follow-up using EQ-5D-3L. Multivariate regression analysis was used to identify determinants of QALYs loss. RESULTS: At 2 weeks, patients with hip fracture (n = 223) reported the lowest mean health state utility value (HSUV) compared with other fracture sites. Thereafter, utility values increased but remained significantly lower than before fracture. For spine (n = 183), humerus (n = 166), and ankle fractures (n = 214), there was a similar pattern of disutility with a nadir within 2 weeks and a progressive recovery thereafter. The accumulated mean QoL loss after hip fracture was 0.5 and significantly greater than after fracture of the distal forearm (0.13), spine (0.21), proximal humerus (0.26), and ankle (0.27). Substantial impairment in self-care and usual activities immediately after fracture were important predictors of recovery across at all fracture sites. CONCLUSIONS: Fractures of the hip, vertebral, distal forearm, ankle, and proximal humerus incur substantial loss of QoL in Russia. The utility values derived from this study can be used in future economic evaluations.

Risk of major osteoporotic fracture after first, second and third fracture in Swedish women aged 50 years and older.

BACKGROUND: Osteoporosis affects approximately one in five European women and leads to fragility fractures, which result in poor health, social and economic consequences. Fragility fractures are a strong risk factor for subsequent major osteoporotic fracture (MOF), with risk of MOF being elevated in the 1-2 years following an earlier fracture, a concept described as "imminent risk". This study examines risk of subsequent MOF in patients with one, two or three prior fractures by age and type of fracture. METHODS: In this retrospective, observational cohort study, Swedish women aged ≥50 years with ≥1 any clinical fragility fracture between July 1, 2006 and December 31, 2012 were identified from Sweden's National Patient Register. Each patient was age- and sex-matched to three controls without history of fracture. Group 1 women included those with one fragility fracture during the study period; Group 2 included those with two fragility fractures; and Group 3 included those with three fragility fractures. "Index fracture" was defined as the first fracture during the study period for Group 1; the second for Group 2; and the third for Group 3. Patients in each cohort and matched controls were followed for up to 60 months or until subsequent MOF (hip, vertebra, forearm, humerus), death or end of data availability. RESULTS: 231,769 women with at least one fracture were included in the study and therefore constituted Group 1; of these, 39,524 constituted Group 2 and of those, 7656 constituted Group 3. At five years, cumulative incidence of subsequent MOF was higher in patients with a history of fracture as compared to controls (Group 1: 20.7% vs 12.3%; Group 2: 32.0% vs 15.3%). Three-year cumulative incidence for Group 3 was 12.1% (vs 10.7% for controls). After adjusting for baseline covariates, risk of subsequent MOF was highest within 0-24 months following an index fracture, then decreased but remained elevated as compared to controls. Having two prior fractures, vertebral fractures and younger age at time of index fracture were associated with greater relative risk. CONCLUSIONS: Women with a history of osteoporotic fracture are at increased risk of subsequent fracture, which is highest during the first 24 months following a fracture. Younger women and those with vertebral fractures are at greatest relative risk, suggesting that treatment should target these patients and be timely enough to impact the period of imminent risk.

Incorporating the Environmental Impact into a Budget Impact Analysis: The Example of Adopting RESPIMAT® Re-usable Inhaler.

BACKGROUND: RESPIMAT® re-usable enables patients to re-use the inhaler and its availability therefore reduces the number of inhalers and associated wastage. OBJECTIVE: The objective of this study was to perform an economic evaluation that incorporates the ecological impact of adopting RESPIMAT re-usable into the healthcare system in Germany. METHODS: Inhaler costs and environmental impact over 5 years in Germany in a scenario with RESPIMAT re-usable compared to a scenario without RESPIMAT re-usable were estimated using a budget impact model. The carbon emissions were derived for each treatment pattern considering the whole life cycle (cradle-to-grave) of the inhaler product. The cost of carbon emissions was estimated using a societal cost per ton of carbon emission. RESULTS: By introducing RESPIMAT re-usable in Germany, it was estimated that by 2023, the number of inhalers used would have decreased by 5,748,750 compared to a scenario without RESPIMAT re-usable. In addition, this measure would reduce the environmental burden of inhaler use while at the same time reducing medical cost of inhalers. CONCLUSIONS: Adopting RESPIMAT® re-usable to the national healthcare services may be a cost-saving option, which has the additional benefit of reducing the societal cost of carbon emissions.

Cost and Health Outcomes Patterns in Patients Treated With Spinal Cord Stimulation Following Spine Surgery-A Register-Based Study.

OBJECTIVE: Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pain, has been shown to be effective in patients with persisting neuropathic pain after spine surgery. However, little is known about the long-term cost and quality-of-life (QoL) patterns in SCS-treated patients. The aim is to describe the use of SCS, costs, pre-spine-surgery and post-spine-surgery QoL, and reported pain intensity, in patients who have undergone spine surgery and subsequent SCS implantation. The results will be related to outcome and cost in spine surgery patients in general. MATERIALS AND METHODS: A research database comprised from six Swedish national and regional registers, and the spine surgery quality-of-care register Swespine was utilized. Two cohorts were identified: all patients who had spine surgery (N = 73,765) and patients who had spine surgery and subsequent SCS implantation (N = 239). Costs were analyzed before and after spine surgery for both cohorts, as well as before and after SCS implantation for the second cohort. QoL was explored by estimating patient-reported outcome measures such as pain intensity, Oswestry Disability Index, and EuroQol-5Dimensions from spine surgery up to five years post-spine surgery. RESULTS: In spine surgery patients, mean QoL and pain intensity levels improved following surgery. Patients subsequently treated with SCS had lower reported QoL and higher costs before the initial spine surgery, and spine surgery did not lead to any substantial improvements, however, costs decreased following SCS implantation in these patients.

A Budget Impact Model to Estimate the Environmental Impact of Adopting RESPIMAT® Re-usable in the Nordics and Benelux.

INTRODUCTION: The healthcare sector contributes 5-8% of the global greenhouse gas emissions. Global and regional organizations and governments have started to design and implement measures to reduce global greenhouse gas emissions in the healthcare sector, e.g. by green public procurement policies and inclusion of ecological considerations in the decision-making process for purchasing and funding of healthcare technologies. The objective of this study was to perform budget impact analysis of adopting RESPIMAT re-usable in the Nordics and Benelux that considered both the traditional healthcare costs as well as the environmental impact. METHODS: Inhaler costs and environmental impact over 5 years in the Nordics and Benelux in a scenario with RESPIMAT re-usable compared to a scenario without RESPIMAT re-usable were estimated using an budget impact model. RESPIMAT re-usable enables patients to re-use the inhaler device and its availability therefore reduces the number of inhalers and associated wastage. The carbon emissions were derived for each treatment pattern considering the whole life cycle (cradle-to-grave) of the inhaler product. The cost of carbon emissions was estimated using a societal cost per ton of carbon emission. RESULTS: Progressively introducing RESPIMAT re-usable in the Nordics and Benelux was estimated to decrease the number of inhalers used by 2023 by 7,466,621 compared to a scenario without RESPIMAT re-usable, which would result in a reduction of the environmental burden of inhaler use of 4717 tCO2e and a decrease in societal cost of €205,888. CONCLUSIONS: Adopting RESPIMAT re-usable would lead to a substantial reduction in CO2 emissions, leading to savings from a societal perspective. FUNDING: Boehringer Ingelheim.

The Association Between Patient Reported Outcomes of Spinal Surgery and Societal Costs: A Register Based Study.

STUDY DESIGN: Retrospective register-based study using Swedish registers and data prospectively collected in quality register Swespine. OBJECTIVE: Analyze the association of societal costs and spine surgery outcome in low back pain (LBP) patients based on patient reported outcome measures (PROMs). SUMMARY OF BACKGROUND DATA: Studies show that LBP has a substantial impact on societal cost. There are indications that the burden diverges over different patient groups, but little is known about cost patterns in relation to PROMs of LBP surgery. METHODS: We utilized a database with data from six registers. All lumbar spine surgery patients registered in Swespine 2000 to 2012 were identified. Swespine collects PROMs Global Assessment of pain improvement (GA), Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and EuroQol five-dimension scale (EQ-5D). A literature search was conducted to identify threshold changes in ODI, VAS, and EQ-5D representing a significant improvement or deterioration as defined by the minimal clinically important difference (MCID). We categorized patients into groups by their GA response at 2-year follow-up and estimated mean changes in ODI, VAS, and EQ-5D for each group. These changes were compared with the MCID thresholds to determine a GA-anchored classification of surgical outcomes. Costs consisted of out/inpatient care, sick leave, early retirement, and pharmaceuticals. RESULTS: In total, 12,350 patients were included. GA 1-2 ("pain has disappeared"/"pain is much improved") were labeled successful surgery outcomes (67%), GA 3 ("pain somewhat improved"), undetermined (16%), and GA 4-5 ("no change in pain"/"pain has worsened") unsuccessful (17%). Costs of the unsuccessful and undetermined were higher than of the successful during the entire study period, with differences increasing markedly post-surgery. For the successful, a downward cost trend was observed; costs almost returned to the level observed 3 years pre-surgery. No such trend was observed in the other groups. CONCLUSION: Identifying patients with higher probability of responding to surgery could lead to improved health and substantial societal cost savings. LEVEL OF EVIDENCE: 3.